ReviewBritish journal of clinical pharmacology2019
Regulatory aspects of the development of drugs for metabolic bone diseases - FDA and EMA perspective.
Review in British journal of clinical pharmacology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
12 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Pharmacologic Treatment of Primary Osteoporosis or Low Bone Mass to Prevent Fractures in Adults: A Living Clinical Guideline From the American College of Physicians.Annals of internal medicine · 2023Guideline
- Image-guided in vivo evaluation and comparison of bone-targeting peptides for therapeutic intervention.Drug delivery and translational research · 2026Article
- Osteoporosis: molecular pathogenesis and therapeutic interventions.Molecular biomedicine · 2025Review
- Advancements in the Field of Protein-Based Hydrogels: Main Types, Characteristics, and Their Applications.Gels (Basel, Switzerland) · 2025Review
- Osteoporosis in Older Men: Informing Patient Management and Improving Health-Related Outcomes.Drugs & aging · 2025Review
- Recommendations for the optimal use of bone forming agents in osteoporosis.Aging clinical and experimental research · 2024Review
- Evidence-Based Guideline for the management of osteoporosis in men.Nature reviews. Rheumatology · 2024Review
- Ethical challenges raised by osteoporosis-related clinical trials.Journal of medical ethics and history of medicine · 2023Article
- The Hitchhiker's Guide to Human Therapeutic Nanoparticle Development.Pharmaceutics · 2022Review
- Are the European Medicines Agency, US Food and Drug Administration, and Other International Regulators Talking to Each Other?Clinical pharmacology and therapeutics · 2020Review
- Drugs for the treatment of metabolic bone diseases.British journal of clinical pharmacology · 2019Article
- Regulatory aspects of the development of drugs for metabolic bone diseases - FDA and EMA perspective.British journal of clinical pharmacology · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Regulation of medicines involves complex scientific and public health policies which are reflected in the regulatory approaches used by the European Medicines Agency and the United States Food and Drug Administration for the approval of products developed for metabolic bone diseases. For osteoporosis therapies, utilized by many patients, the approaches and existing guidance for product development of both agencies are similar; confirmatory studies for the approval of osteoporosis products can rely on well-defined efficacy outcome parameters. Therapeutics for rare bone diseases, a rapidly expanding area, often require an individualized regulatory approach. This review outlines key aspects of these regulatory approaches applied by the two agencies for products for metabolic bone diseases.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.